Medical Device Manufacturer · US , San Antonio , TX

Germaine Laboratories, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1997

Recent clearances: MIDSTREAM HOME REGNANCY TEST

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Germaine Laboratories, Inc. Chemistry ✕

8 devices

1-8 of 8

Cleared Oct 26, 2005

AIMSTICK URINE REAGENT STRIPS

Chemistry · 120d

Cleared Jan 22, 2002

AIMSTEP PREGNANCY

Chemistry · 62d

Cleared May 10, 1999

ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY

Chemistry · 20d

Cleared Apr 16, 1998

AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST

Chemistry · 16d

Cleared Mar 06, 1998

AIMSTEP PREGNANCY

Chemistry · 23d

Cleared Jan 02, 1998

AIMSTICK PBD PREGNANCY

Chemistry · 43d

Cleared Jan 02, 1998

AIMSTICK PBD COMBO PREGNANCY

Chemistry · 32d

Cleared Dec 19, 1997

MIDSTREAM HOME REGNANCY TEST

Chemistry · 73d